Antigen Rapid Test

An aid to identifying people infected by SARS-CoV-2

The SARS-CoV-2 Antigen Rapid Test is a rapid and reliable chromatographic immunoassay for the qualitative detection of specific SARS-CoV-2 antigens present in the human nasopharynx. This test is an aid to detect the SARS-CoV-2 virus antigen in people suspected of having COVID-19. This product is strictly designed for professional use in laboratory and point-of-care environments.

SARS-CoV-2: an overview of the structure, transmission and detection of the virus

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an enveloped single-stranded RNA virus of the Coronaviridae family. Coronaviruses share structural similarities and are composed of 16 nonstructural proteins and 4 structural proteins: spike (S), envelope (E), membrane (M), and nucleocapsid (N).

Coronaviruses cause illnesses with symptoms ranging from those of a mild common cold to more severe ones such as coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. SARS-CoV-2 is transmitted from person to person mainly through respiratory droplets, although indirect transmission through contaminated surfaces is also possible. The virus gains access to host cells through the angiotensin-converting enzyme 2 (ACE2) receptor, which is more abundant in the lungs.

The incubation period for COVID-19 ranges from 2 to 14 days after exposure, with most cases showing symptoms approximately 4 to 5 days after exposure. The spectrum of symptomatic infection ranges from mild (fever, cough, fatigue, loss of smell and taste, difficulty breathing) to critical. While most symptomatic cases are not severe, severe disease occurs predominantly in older adults or those with underlying medical comorbidities and requires intensive care. Acute respiratory distress syndrome (ARDS) is a major complication in patients with severe disease. Critical cases are characterized, for example, by respiratory failure, shock and/or multi-organ dysfunction or failure.

Ready-to-use tests when you need to know

The reliable SARS-CoV-2 Antigen Rapid Test provides quick answers where you need them. It’s time to expand testing because patients and their communities need to know.

The benefit of having a SARS-CoV-2 antigen test available

The SARS-CoV-2 virus causes respiratory tract infection. It is mainly transmitted through respiratory droplets after close contact, and primary viral replication is assumed to occur in the mucosal epithelium of the upper respiratory tract (nasal cavity and pharynx). In these locations, the viral load reaches its peak. peak within the first week after symptom onset, and then decline.

A SARS-CoV-2 antigen test detects the presence of SARS-CoV-2 virus from upper respiratory tract swab samples by identifying a nucleoprotein that carries the virus. The test identifies current infection during the acute phase of COVID-19, while the virus is still present in large numbers in the respiratory tract.

Features and benefits of the SARS-CoV-2 Antigen Rapid Test

In addition to laboratory PCR tests, antigen assays can also be offered as rapid tests in near-patient settings. The SARS-CoV-2 Antigen Rapid Test is a rapid chromatographic immunoassay intended for the qualitative detection of SARS-CoV-2 specific antigens present in nasopharyngeal or combined nasopharyngeal/oropharyngeal specimens. This test is designed to detect the SARS-CoV-2 virus antigen in people suspected of having COVID-19. This product is strictly designed for professional use in laboratory and point-of-care environments. Similar to laboratory instruments, it detects a SARS-CoV-2 antigen, the nucleoprotein.

Therefore, it can be used to assess whether a person is infected with SARS-CoV-2 by providing a qualitative result showing coloured bands indicating the presence of SARS-CoV-2 antigens. The SARS-CoV-2 Antigen Rapid Test enables rapid decision-making, e.g. if patients need to be quarantined, reducing the risk of further spread. In addition to that, it allows the detection of people after a confirmed exposure to a person infected with SARS-CoV-2 or people at risk of exposure, such as health workers.

The SARS-CoV-2 Antigen Rapid Test enables decentralized point-of-care testing and helps expand the range and quantity of direct virus testing in otherwise inaccessible locations. Rapid point-of-care tests may sometimes be the only viable option if laboratory tests are not sufficiently available. In addition to that, the rapid SARS-CoV-2 antigen test is an instrument-free test, which allows testing in rural areas or areas with little infrastructure.

The benefits of the rapid SARS-CoV-2 antigen test in brief:

  • Get a quick result in 15 to 30 minutes, without the need for a follow-up appointment to discuss the result
  • Easy handling that does not require specific training
  • No instrument required
  • Allow decentralized testing or access to testing in areas where laboratory testing is not available

Test Kit Information

The kit is ready to use and contains all the equipment needed to perform a test. The following components are required for a test and are included in the kit:

  • Test Device (individually in a foil bag with desiccant)
  • Extraction buffer tube
  • nozzle cap
  • sterile swab
  • Film (can be placed on the test device when testing outdoors)
  • Instructions for use
  • quick reference guide